Clinical trial · Interventional
The DANTE Trial. A Randomized Study on Lung Cancer Screening With Low-Dose Spiral Computed Tomography
NCT00420862CI-TRIAL-00000558terminatedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
High survival rates have been reported for screen-detected Stage I lung cancer patients, but there are concerns about the potential biases of uncontrolled studies. DANTE is a prospective randomized controlled trial exploring the effects of screening with LDCT on lung-cancer-specific mortality, and on the prevalence and incidence rates of lung cancer, stage distribution and resectability rates in a selected high-risk population. The prevalence of a set of biomarkers in sputum and blood samples is also being determined.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Spiral Computed Tomography | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 60 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Male sex * Age 60-74 years * smokers of more than 20 cigarettes/day for at least 20 years (actual smokers or ex-smokers from no more than 10 years) Exclusion Criteria: * severe cardiopathy * advanced BPCO with chronic hypoxaemia (rest SatO2 \< 94%) * chronic severe renal insufficiency * hypertension not controlled with drugs * type 2 diabetes or other severe systemic disease * severe previous cerebrovascular lesions with permanent invalidity (not self-sufficient). * severe vascular lesions with repeated ictus, trophic lesions, or limb loss, if actual smoker * Dementia, psychosis, severe depression or maniac-depressive syndrome * actual or precedent neoplasia, excepted skin tumor not-melanoma or scaly cells laryngeal and buccal cavity tumor, N0, recovered from more than 10 years or other tumors recovered from more than 10 years * transplantation less than 5 years or with rejection episodes in the last 2 years * unable subjects
References
Publications (1)
- DERIVEDInfante M, Lutman FR, Cavuto S, Brambilla G, Chiesa G, Passera E, Angeli E, Chiarenza M, Aranzulla G, Cariboni U, Alloisio M, Incarbone M, Testori A, Destro A, Cappuzzo F, Roncalli M, Santoro A, Ravasi G; DANTE Study Group. Lung cancer screening with spiral CT: baseline results of the randomized DANTE trial. Lung Cancer. 2008 Mar;59(3):355-63. doi: 10.1016/j.lungcan.2007.08.040. Epub 2007 Oct 23. PMID 17936405